Applicability of the fish embryo acute toxicity (FET) test (OECD 236) in the regulatory context of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)

Sobańska, Marta A.; Scholz, Stefan; Nyman, Anna-Maija; Cesnaitis, Romanas; Alonso, Simon Gutierrez; Klüver, Nils; Kühne, Ralph; Tyle, Henrik; Knecht, Joop de; Dang, ZhiChao; Lundbergh, Ivar; Carlon, Claudio; Coen, Wim De

doi:10.1002/etc.4055

Cited by 108 publications

(88 citation statements)

References 44 publications

(66 reference statements)

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“…After significant international validation efforts (Busquet et al 2014), an extension of the test from 48 to 96 h in duration, and omission of the term “replacement to fish acute toxicity” in the introduction of the test guideline (TG), the FET test was finally accepted as an OECD test guideline nearly 8 y later (OECD 2013). However, its universal acceptance as a replacement to the acute fish toxicity test (OECD 1992) has remained an issue because regulators, such as the European Chemicals Agency (ECHA), have not accepted it as a complete replacement (Sobanska et al 2018). A conservative approach to the acceptance of the FET test has been argued due to the existence of some limitations (e.g., neurotoxic mode of action [MoA]) and/or remaining uncertainties (e.g., deviation of some narcotic substances) regarding the FET test (Sobanska et al 2018).…”

Section: Introductionmentioning

confidence: 99%

“…However, its universal acceptance as a replacement to the acute fish toxicity test (OECD 1992) has remained an issue because regulators, such as the European Chemicals Agency (ECHA), have not accepted it as a complete replacement (Sobanska et al 2018). A conservative approach to the acceptance of the FET test has been argued due to the existence of some limitations (e.g., neurotoxic mode of action [MoA]) and/or remaining uncertainties (e.g., deviation of some narcotic substances) regarding the FET test (Sobanska et al 2018). Furthermore, it was concluded that “the FET test alone is currently not sufficient to meet the essential information on AFT as required by the REACH regulation” (Sobanska et al 2018).…”

Section: Introductionmentioning

confidence: 99%

“…A conservative approach to the acceptance of the FET test has been argued due to the existence of some limitations (e.g., neurotoxic mode of action [MoA]) and/or remaining uncertainties (e.g., deviation of some narcotic substances) regarding the FET test (Sobanska et al 2018). Furthermore, it was concluded that “the FET test alone is currently not sufficient to meet the essential information on AFT as required by the REACH regulation” (Sobanska et al 2018). This is despite Sobanska et al (2018) and other authors (Belanger et al 2013) describing a near perfect 1:1 correlation between toxicity values (EC50 and LC50) from the FET and the AFT tests.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of a Bayesian Network for Strengthening the Weight of Evidence to Predict Acute Fish Toxicity from Fish Embryo Toxicity Data

Lillicrap

Moe

Wolf

et al. 2020

Integr Envir Assess & Manag

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The use of fish embryo toxicity (FET) data for hazard assessments of chemicals, in place of acute fish toxicity (AFT) data, has long been the goal for many environmental scientists. The FET test was first proposed as a replacement to the standardized AFT test nearly 15 y ago, but as of now, it has still not been accepted as a standalone replacement by regulatory authorities such as the European Chemicals Agency (ECHA). However, the ECHA has indicated that FET data can be used in a weight of evidence (WoE) approach, if enough information is available to support the conclusions related to the hazard assessment. To determine how such a WoE approach could be applied in practice has been challenging. To provide a conclusive WoE for FET data, we have developed a Bayesian network (BN) to incorporate multiple lines of evidence to predict AFT. There are 4 different lines of evidence in this BN model: 1) physicochemical properties, 2) AFT data from chemicals in a similar class or category, 3) ecotoxicity data from other trophic levels of organisms (e.g., daphnids and algae), and 4) measured FET data. The BN model was constructed from data obtained from a curated database and conditional probabilities assigned for the outcomes of each line of evidence. To evaluate the model, 20 data‐rich chemicals, containing a minimum of 3 AFT and FET test data points, were selected to ensure a suitable comparison could be performed. The results of the AFT predictions indicated that the BN model could accurately predict the toxicity interval for 80% of the chemicals evaluated. For the remaining chemicals (20%), either daphnids or algae were the most sensitive test species, and for those chemicals, the daphnid or algal hazard data would have driven the environmental classification. Integr Environ Assess Manag 2020;16:452–460. © 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC)

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Evaluation of a Bayesian Network for Strengthening the Weight of Evidence to Predict Acute Fish Toxicity from Fish Embryo Toxicity Data

Lillicrap

Moe

Wolf

et al. 2020

Integr Envir Assess & Manag

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“…Previous reviews and comments on the specific case of TiO 2 are published by the parties involved in the process, namely, the authorities (ANSES 2016;ECHA 2017a) and industry (CEPE 2017;TDMA 2018). The other previous research on REACH and CLP focuses largely on various test methods and their applicability in a regulatory context (e.g., Cappelli et al 2015;Alépée et al 2017;Sobanska et al 2017) and in the specific impacts of REACH and CLP on products and applications that are not directly within the scope of these regulations, such as wastes and recycling (Bodar et al 2018), as well as food materials (Geueke and Muncke 2017). Moreover, references to bending regulatory situation for substance groups regarding their assessment according to REACH, for example, nanomaterials and plastics, are discussed (Walser and Studer 2014;Raucher et al 2016;Steensgaard et al 2017;Drobne 2018).…”

Section: Previous Studies Related To Tio 2 Classificationmentioning

confidence: 99%

Is It Safe to Paint Your Wall White? A Case Study on Titanium Dioxide Classification

Kähkönen

2019

Integr Envir Assess & Manag

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Titanium dioxide (TiO2) is in the process of being classified as a suspected carcinogenic substance (Carc 2). The present case study probes the outcomes of this potential classification in terms of the reduction of hazardous exposure to TiO2 due to its classification. Furthermore, the case study examines the elements that are causing ambiguity during the classification process. This study was conducted by walking through the process from the present exposure to TiO2 to the hazard assessment associated with TiO2 exposure, to the regulatory classification process, and to practical outcomes affecting TiO2 usage. Finally, the impact of the classification on exposure, which was originally considered potentially hazardous, is evaluated. The case study shows that TiO2 classification as a carcinogen will not directly reduce respiratory exposure to TiO2, which was the original reason for the classification. Instead, the classification will lead to restrictions on recycling. Moreover, the classification will have an impact on certain solid artifacts and liquid mixtures for which hazardous exposure was not detected. Altogether, the present case raises questions concerning hazard communications associated with the Carc 2 classification; treatment of poorly soluble low toxicity (PSLT) particles and nanoparticles in the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Classification, Labelling and Packaging (CLP) classifications; and use of human exposure studies for the purposes of chemical regulations. Based on the present study, the following recommendations are made: the final decision on the TiO2 classification should be reconsidered together with those of other PSLT particles and take into account extensive developments in the field of nanoscience. Furthermore, the European Chemicals Agency (ECHA) should develop state‐of‐the‐art guidance on how to use the available human exposure data. Finally, the authorities that are in charge of European Union chemicals management are advised to further develop the regulatory network to utilize the information generated in REACH processes as efficiently as possible and to verify that the connections between the regulations result in the intended outcome. Integr Environ Assess Manag 2019;00:1–12. © 2019 SETAC

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“…Previous studies show a good correlation of FET with the standard acute fish toxicity (AFT) test (Belanger et al, 2013; Rawlings et al, 2019). Nevertheless, it has been found that the fish embryo toxicity test alone is currently not sufficient to replace the acute fish toxicity data as required by the European REACH regulation (Regulation, Evaluation, Authorisation and Restriction of Chemicals) (Sobanska et al, 2018). However, the authors have suggested that “the test may be used within weight-of-evidence approaches together with other independent, relevant, and reliable sources of information”.…”

Section: Introductionmentioning

confidence: 99%

Development of a hybrid Bayesian network model for predicting acute fish toxicity using multiple lines of evidence

Moe

Madsen

Connors

et al. 2019

Preprint

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A Bayesian network was developed for predicting the acute toxicity intervals of chemical substances to fish, based on information on fish embryo toxicity (FET) in combination with other information. This model can support the use of FET data in a Weight-of-Evidence (WOE) approach for replacing the use of juvenile fish. The BN predicted correct toxicity intervals for 69%-80% of the tested substances. The model was most sensitive to components quantified by toxicity data, and least sensitive to components quantified by expert knowledge. The model is publicly available through a web interface. Further development of this model should include additional lines of evidence, refinement of the discretisation, and training with a larger dataset for weighting of the lines of evidence. A refined version of this model can be a useful tool for predicting acute fish toxicity, and a contribution to more quantitative WOE approaches for ecotoxicology and environmental assessment more generally.HighlightsA Bayesian network (BN) was developed to predict the toxicity of chemicals to fishThe BN uses fish embryo toxicity data in a quantitative weight-of-evidence approachThe BN integrates physical, chemical and toxicological properties of chemicalsCorrect toxicity intervals were predicted for 69-80% of test casesThe BN is publicly available for demonstration and testing through a web interface

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Applicability of the fish embryo acute toxicity (FET) test (OECD 236) in the regulatory context of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)

Cited by 108 publications

References 44 publications

Evaluation of a Bayesian Network for Strengthening the Weight of Evidence to Predict Acute Fish Toxicity from Fish Embryo Toxicity Data

Evaluation of a Bayesian Network for Strengthening the Weight of Evidence to Predict Acute Fish Toxicity from Fish Embryo Toxicity Data

Is It Safe to Paint Your Wall White? A Case Study on Titanium Dioxide Classification

Development of a hybrid Bayesian network model for predicting acute fish toxicity using multiple lines of evidence

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